Women's Ischemia Syndrome Evaluation (WISE)

BACKGROUND:

Cardiovascular disease exacts a heavy burden on the health of women. Ischemic heart disease claims the lives of nearly 250,000 women in the United States each year. Recognition of ischemic heart disease in women is a major challenge to the primary care physician. Diagnosis of ischemic heart disease requires recognition of clinical symptoms such as chest pain, or events such as a myocardial infarction, which are evaluated by a physician who will confirm the diagnosis with objective tests. Unfortunately, both symptom recognition and diagnostic tests confuse rather than confirm a diagnosis of myocardial ischemia in women. Chest pain syndromes suspicious for myocardial ischemia are common in women. Noninvasive diagnostic methods which often confirm the diagnosis and assess disease severity in men are less reliable in women. This lack of objective data to support the diagnosis of chronic or acute myocardial ischemia may influence the physician's decision to further evaluate women at risk. With precision in diagnosis, efforts to optimize therapies are hampered.

The detection of epicardial coronary atherosclerosis is a major objective in clinical cardiology. The utility of this approach is well established. However, although the presence of atherosclerosis is sufficient to cause myocardial ischemia, whether significant ischemia or risk of ischemia exists in the absence of angiographic epicardial stenosis, is not known and may be important for women.

Recent progress in understanding the pathophysiology of myocardial ischemia provides a more complex causal pathway than the heretofore notion of fixed atherosclerotic obstructions in passive conduits. Diseased arteries which may appear angiographically normal as well as arteries with fixed obstructions can respond to vasomotor influences with a detrimental amount of vasoconstriction. The endothelium generates vasoactive and anticoagulant factors that are important mediators of thrombosis. Cycling hormones may further influence these complex interactions. Methods which do not rely solely on fixed obstruction of epicardial arteries are not only possible but may be useful to recognize early atherosclerosis or, for example, endothelial dysfunction which places the patient at risk for untoward coronary events.

The concept for the study was developed by the Cardiology Advisory Committee in collaboration with staff and was approved by the May 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in April 1994.